Nicotine DependenceSistersNCT02083081
Community Intervention to Reduce Tobacco Use in Pregnant Women
A study testing Community level intervention in people with Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
Trial summary
In the southwest region of Alaska where the project takes place, 79% of Alaska Native women smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy appears to be a high risk period for initiation of tobacco use, primarily ST, among women reporting no use of tobacco 3 months before… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Community level intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Alaska Native
- >18 years of age
- able to provide written informed consent
- currently pregnant and at < 26 weeks gestation
- has access to a working telephone.
Who cannot join
- plans to have an abortion
Trial locations and contacts
1 site in 1 country.
United States1 site
Yukon Kuskokwim Health Corporation
Bethel, Alaska, 99559
About this study
Official title: Community Intervention to Reduce Tobacco Use Among Alaska Native Pregnant Women
In the southwest region of Alaska where the project takes place, 79% of Alaska Native women smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy appears to be a high risk period for initiation of tobacco use, primarily ST, among women reporting no use of tobacco 3 months before pregnancy. Intervention efforts targeting the entire community, not only pregnant women, to address social norms about tobacco use may be effective. Thus, the investigators will evaluate the efficacy of a novel, multi-component, theory-based intervention for reducing tobacco use during pregnancy, incorporating both individually targeted and community level components delivered by female elders "Native Sisters." The intervention builds on effective community and individual-based approaches for tobacco cessation and lay health advisor approaches for cancer prevention among Native American women. As part of the intervention, a social marketing campaign including digital stories and other small media will be developed with community feedback. Individually targeted components will be six 30-40 minute telephone or home-based peer counseling sessions with pregnant women.
Read the detailed description
The project will be conducted in two phases. In Phase I, the investigators will develop the social marketing components by obtaining qualitative feedback from pregnant women, family members and elders on message content and delivery channels. In Phase II, the investigators will evaluate the intervention using a group-randomized design with village as the unit of assignment. Sixteen villages will be randomly assigned to receive the intervention or control condition (usual care), with > 20 pregnant women enrolled from each village. Assessments will be completed by enrolled women through 6 months postpartum. All aspects of the project will be guided by a Community Advisory Committee.
The Specific Aims are:
Aim 1. To develop and pre-test the social marketing campaign messages and delivery channels through focus groups and individual interviews of pregnant women, family members, and elders. The focus group work will assess reasons for initiating or continuing tobacco use during pregnancy and the potential role of other community members in addressing tobacco use in pregnancy. Findings will be used to develop campaign messages and media that will be pre-tested through individual interviews and refined. Session content for the individually targeted intervention components will also be developed to align with the campaign messages.
Aim 2. To evaluate the efficacy of the intervention compared with the control condition on the biochemically confirmed 7-day point prevalence tobacco use rate at week 36 gestation and at 6 months postpartum.
Hypothesis: Compared with the control condition, the intervention will be associated with significantly lower rates of tobacco use in late pregnancy (80% vs. 65%) and at 6 months postpartum (70% vs. 55%).
Aim 3. To examine the effect of the intervention on proposed social cognitive-theory based mediators of change including perceived social norms about tobacco use and self-efficacy for non-tobacco use.
Hypothesis: Intervention effects on tobacco use at week 36 gestation and at 6 months postpartum will be mediated by perceived self-efficacy and anti-tobacco norms.
- Conditions
- Nicotine Dependence
- Being tested
- Community level intervention
- Keywords
- tobacco, smoking
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community level interventionBehavioural
Community intervention plus individual counseling
| Study group | Role | What they receive |
|---|---|---|
| community intervention | Experimental | Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Receives: Behavioral: Community level intervention |
| usual care | No intervention | Usual care provided by health aides to pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tobacco Abstinence at 6-months Post-partum
Total number of participants to have biochemically confirmed tobacco abstinence at 6-months post-partum
Measured: 6 months postpartum
Number of Participants With Tobacco Abstinence at End of Pregnancy
Total number of participants to have biochemically confirmed tobacco abstinence at end of pregnancy (delivery).
Measured: Approximately 9 months
Secondary outcomes (1)
Change in Self-efficacy for Non-tobacco Use Scores
Change from baseline in self-efficacy for non-tobacco use scores measured by the self-reported Smoking Confidence Questionnaire. Total scores range from 0-30, higher scores indicate better outcome.
Measured: Baseline, 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Yukon Kuskokwim Health Corporation, University of Minnesota, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
- Investigators
- Christi A Patten, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083081
- Sponsor's protocol ID
- 13-008824
- Other IDs
- 1R01CA164533
- Acronym
- Sisters
- Status last verified
- Jun 2022
- First submitted
- 5 Mar 2014
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Intervention to Reduce Tobacco Use Among Alaska Native Pregnant Women
- ClinicalTrials.gov ID
- NCT02083081
- Acronym / sponsor ID
- Sisters / 13-008824
- Conditions
- Nicotine Dependence
- Keywords
- tobacco, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Yukon Kuskokwim Health Corporation, University of Minnesota, National Cancer Institute (NCI)
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the southwest region of Alaska where the project takes place, 79% of Alaska Native women smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy appears to be a high risk period for initiation of tobacco use, primarily ST, among women reporting no use of tobacco 3 months before pregnancy. Intervention efforts targeting the entire community, not only pregnant women, to address social norms about tobacco use may be effective. Thus, the investigators will evaluate the efficacy of a novel, multi-component, theory-based intervention for reducing tobacco use during pregnancy, incorporating both individually targeted and community level components delivered by female elders "Native Sisters." The intervention builds on effective community and individual-based approaches for tobacco cessation and lay health advisor approaches for cancer prevention among Native American women. As part of the intervention, a social marketing campaign including digital stories and other small media will be developed with community feedback. Individually targeted components will be six 30-40 minute telephone or home-based peer counseling sessions with pregnant women.
Detailed description
The project will be conducted in two phases. In Phase I, the investigators will develop the social marketing components by obtaining qualitative feedback from pregnant women, family members and elders on message content and delivery channels. In Phase II, the investigators will evaluate the intervention using a group-randomized design with village as the unit of assignment. Sixteen villages will be randomly assigned to receive the intervention or control condition (usual care), with > 20 pregnant women enrolled from each village. Assessments will be completed by enrolled women through 6 months postpartum. All aspects of the project will be guided by a Community Advisory Committee.
The Specific Aims are:
Aim 1. To develop and pre-test the social marketing campaign messages and delivery channels through focus groups and individual interviews of pregnant women, family members, and elders. The focus group work will assess reasons for initiating or continuing tobacco use during pregnancy and the potential role of other community members in addressing tobacco use in pregnancy. Findings will be used to develop campaign messages and media that will be pre-tested through individual interviews and refined. Session content for the individually targeted intervention components will also be developed to align with the campaign messages.
Aim 2. To evaluate the efficacy of the intervention compared with the control condition on the biochemically confirmed 7-day point prevalence tobacco use rate at week 36 gestation and at 6 months postpartum.
Hypothesis: Compared with the control condition, the intervention will be associated with significantly lower rates of tobacco use in late pregnancy (80% vs. 65%) and at 6 months postpartum (70% vs. 55%).
Aim 3. To examine the effect of the intervention on proposed social cognitive-theory based mediators of change including perceived social norms about tobacco use and self-efficacy for non-tobacco use.
Hypothesis: Intervention effects on tobacco use at week 36 gestation and at 6 months postpartum will be mediated by perceived self-efficacy and anti-tobacco norms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| community intervention | Experimental | Behavioral: Community level interventionCommunity level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women |
| usual care | No intervention | –Usual care provided by health aides to pregnant women |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Alaska Native
- >18 years of age
- able to provide written informed consent
- currently pregnant and at < 26 weeks gestation
- has access to a working telephone.
Key exclusion criteria (1 listed)
- plans to have an abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community level interventionCommunity intervention plus individual counseling | Behavioural | community intervention |
Primary outcome
Number of Participants With Tobacco Abstinence at 6-months Post-partum
Time frame: 6 months postpartum
Total number of participants to have biochemically confirmed tobacco abstinence at 6-months post-partum
Number of Participants With Tobacco Abstinence at End of Pregnancy
Time frame: Approximately 9 months
Total number of participants to have biochemically confirmed tobacco abstinence at end of pregnancy (delivery).
1 secondary outcome
Change in Self-efficacy for Non-tobacco Use Scores
Time frame: Baseline, 6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christi A Patten, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community level intervention in people with Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Tobacco Abstinence at 6-months Post-partum (time frame: 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.